UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Title of the study (Brief title)	A study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of exercise and dietary supplements on morphological and mechanical characteristics of human soft tissues and physical functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Thickness of skeletal muscles
Key secondary outcomes	-Body height, mass and composition -Skeletal muscle mass -Muscle strength -Subcutaneous adipose tissue thickness at the thigh -3D body shape measurement -Dietary intake

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Intake of the test dietary supplements for 3 months.
Interventions/Control_2	Intake of the placebo supplements and exercise for 3 months.
Interventions/Control_3	Intake of the test dietary supplements and exercise for 3 months.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	Healthy women with no regular exercise habit.
Key exclusion criteria	-Persons currently suffering from diseases. -Persons with food allergies. -Persons pparticipating in other tests. -Persons suffering from pain due to bone fracture, muscle sprain or strain injuries. -Persons who are or may be pregnant. -Persons who are breastfeeding. -Persons with claustrophobia. -Persons with implanted metallic materials (pacemakers, artificial joints etc.).
Target sample size	36

Research contact person
Name of lead principal investigator	Yasuo Kawakami
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa city, Saitama
TEL	04-2947-6784
Email	ykawa@waseda.jp

Public contact
Name of contact person	Yasuo Kawakami
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa city, Saitama
TEL	04-2947-6784
Homepage URL
Email	ykawa@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Shiseido Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	早稲田大学所沢キャンパス（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 17 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026191